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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RIMMED SPEED PIN - 45MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

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SMITH & NEPHEW, INC. RIMMED SPEED PIN - 45MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 74013471
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/24/2023
Event Type  Injury  
Event Description
A trial tibia tray was inserted and pinned in place to confirm sizing and rotation.This was noted to just avoid the metal tibial interference screw so it did not have to be extracted.The anterior pin that was drilled contacted the interference screw and snapped, but the retained segment was threaded and buried in bone so was left in place so as not to disrupt any of the proximal metaphyseal bone.
 
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Brand Name
RIMMED SPEED PIN - 45MM
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
MDR Report Key17097950
MDR Text Key316973368
Report NumberMW5118283
Device Sequence Number1
Product Code HSX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number74013471
Device Lot Number19JNX0047
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/08/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age60 YR
Patient SexMale
Patient Weight91 KG
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